WO2018109246A1 - Dispositif fermé et stérile pour la séparation et la concentration aseptiques de composants biologiques - Google Patents
Dispositif fermé et stérile pour la séparation et la concentration aseptiques de composants biologiques Download PDFInfo
- Publication number
- WO2018109246A1 WO2018109246A1 PCT/ES2017/070768 ES2017070768W WO2018109246A1 WO 2018109246 A1 WO2018109246 A1 WO 2018109246A1 ES 2017070768 W ES2017070768 W ES 2017070768W WO 2018109246 A1 WO2018109246 A1 WO 2018109246A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tube
- piston
- buoy
- separated
- fluid
- Prior art date
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
- G01N33/491—Blood by separating the blood components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2079—Filtering means
- A61J1/2086—Filtering means for fluid filtration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1412—Containers with closing means, e.g. caps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
- A61B5/154—Devices using pre-evacuated means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
Definitions
- the object of the present invention is a closed and sterile device for the separation and aseptic concentration of biological components, such as blood, plasma, adipose tissue, cells or any other.
- This invention has characteristics oriented to allow researchers, scientists, biologists, doctors and veterinarians, to separate and concentrate different liquids, tissues or body fluids aseptically in a closed device by means of density gradients and / or differential centrifugation, to then be analyzed , studied and applied "in vitro” and "in vivo” without problems of external / environmental contamination by pathogens, bacteria, etc.
- the closed and sterile device for the separation and aseptic concentration of biological components object of the invention, has technical characteristics aimed at solving the aforementioned problems and allowing permeability inside a separation tube through a valve mounted on a plunger of closing of the interior of the tube, without risks of contamination and safety for the user.
- the device comprises at least: - a tube, closed at a first end and having a mouth at a second end;
- a piston of flexible material without a drive rod, mounted inside the tube with the possibility of longitudinal displacement and that has a loading and unloading orifice of a fluid to be concentrated and separated into various fractions, whose orifice is provided with a luer-lock valve female connection; and of a conduit, provided with a self-sealing filter, through which automatic purging of the air / gas contained in the tube is performed during the filling of the tube with the fluid to be separated and concentrated and,
- connection / piston assembly attachable to the mouth of the tube.
- the piston provided with the female luer-lock valve connection allows, by coupling a syringe with male luer-lock connection, to load the blood or liquid to be treated and the subsequent extraction of the fractions obtained after centrifugation through of the piston and of the mentioned female luer-lock valve valve connection; performing said operations, in a safe, fast and reliable manner, as many times as necessary, without uncovering the tube and without using needles or other elements to pierce the plunger, avoiding contamination of the inside of the tube.
- the plunger has a concave anterior end provided with radial fins to avoid turbulence and favor precise fractionation, controlling fluid dynamics and stabilizing the passage of the separated liquid fraction from inside the cylinder to a syringe of extraction coupled to the plunger connection.
- Said piston has a lateral surface with a defined perimeter recess between adjusting rings that guarantee a good seal inside the tube and avoid excessive friction of the piston with the tube.
- this device does not use needles, avoiding risks for the user and risks of contamination.
- Another advantage of this device is that the female luer-lock connection coupled to the piston does not have dead spaces in its outer part where significant fractions of the introduced or removed fluids may be retained, which would be exposed to contamination.
- the protective cap incorporates an absorbent filler inside that protects and externally dries the female luer-lock connection of possible drops of the fluids to be separated and concentrated, and provides permeability to the environment, avoiding contamination risks.
- This plug provides a protection of the connection / plunger assembly preventing its contamination, preventing its eventual contact with any object during the manipulation of the tube by the user, and its contact with the suspended particles displaced by the air currents that occur during the centrifugation of the tube contents.
- the device comprises inside the tube a cylindrical buoy, of a predetermined density, of a diameter suitable to the diameter of the inside of the tube and provided with a central hole with a unidirectional valve for the passage of the fractions denser towards the area located by under the buoy and thus float on a denser fraction, although the starting position of the buoy is the lower end of the tube, and said buoy is very tight to the walls of the tube, but without being locked in it; enough to slide and to remain stable without oscillations.
- Said buoy is intended to be positioned by flotation between the fractions obtained after a centrifugation of the fluid to be separated forming a physical barrier between fractions of different density, floating above the denser fractions than itself.
- said buoy has a concave upper face that ends at the central hole of fluid passage through the buoy.
- This device is designed to be used in centrifugal equipment that has the appropriate size to be able to introduce it inside and have software that, depending on the objective, can be separated and concentrated in a flexible way that fluid (e.g. in the case of blood) more or less concentrated fractions can be removed, of greater or lesser volume.
- Figure 1 shows an elevational view of an embodiment example of the closed and sterile device for the separation of aseptic concentration of biological components, with the cap in the open position.
- FIG. 3 shows an elevation view of the device of the previous figures during the loading of the fluid to be separated inside the tube by means of a loading syringe provided with a male “luerlock” connection, complementary to the “luer” connection. lock “female piston valve, and coupled with it.
- FIG. 5 shows a view of the device of the previous figures during the extraction of one of the liquid fractions by means of an extraction syringe coupled to the luer-lock connection of the plunger, and establishing said piston contact, by means of its perimeter lip , with the perimeter chamfer of the buoy.
- the closed and sterile device for the separation and aseptic concentration of biological components comprises a tube (1) with a first end (1 1) closed and having a mouth (12) at a second end.
- Said plunger (2) has an orifice (21) for loading a fluid to be separated and concentrated in various fractions, and for discharging the fractions of said fluid, of different density, separated by centrifugation.
- the orifice (21) has at the end oriented towards the mouth (12) of the tube (1) of a female luer-lock connection (22), whose valve is normally held in a closed position and opens when coupled with a luer-lock male connection (CM).
- CM luer-lock male connection
- the piston (2) also has a conduit (23) for automatic purging of the air / gas contained in the tube (1) during the filling of the tube (1) with the fluid to be separated and concentrated, this filling operation being carried out by means of a loading syringe (JC) provided with a male "luerlock” connection (CM) complementary to that of the piston (2), as shown in Figure 3.
- JC loading syringe
- CM male "luerlock” connection
- Said purge conduit (23) is provided with a self-sealing filter (24) comprising a gelling filler which, when in contact with the fluid to be separated due to the complete filling of the tube (1) and is moistened with said fluid, gels and Seals immediately, losing its permeability to air / gas and liquids.
- a self-sealing filter (24) comprising a gelling filler which, when in contact with the fluid to be separated due to the complete filling of the tube (1) and is moistened with said fluid, gels and Seals immediately, losing its permeability to air / gas and liquids.
- the piston (2) has a concave anterior end (25), oriented towards the first end (11) of the tube (1) and provided with radial fins (25), which avoid turbulence and favor precise fractionation, stabilizing the passage of the liquid fraction separated from inside the tube (1) to an extraction syringe (JE) coupled to the female "luer-lock” connection (22) valved from the plunger (2) by means of a male "luer-lock” connection (CM) complementary, as shown in Figure 5.
- This extraction syringe (JE) has a smaller diameter than the tube (1) acting in the coupling position as the piston rod (2).
- the piston has on its side surface a perimeter recess (27) defined between adjusting rings (28) with the inside of the tube (1).
- the device comprises a protection plug (3) of the connection / piston assembly, attachable to the mouth (12) of the tube (1).
- This protective cap (3) incorporates in its interior an absorbent filler (31) that protects and dries the female luer-lock connection (22) of the piston (2) from possible drops of the fluids to be separated and concentrated, avoiding contamination risks .
- Said buoy (4) has a concave upper face (43) that ends, internally, in the central hole (41) of fluid passage through the buoy (2) and, externally, in a perimeter chamfer (44).
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Physics & Mathematics (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- Biophysics (AREA)
- Medical Informatics (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Fluid Mechanics (AREA)
- Urology & Nephrology (AREA)
- Ecology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- External Artificial Organs (AREA)
- Sampling And Sample Adjustment (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
Abstract
L'invention concerne un dispositif fermé et stérile pour la séparation et la concentration aseptiques de composants biologiques, qui comprend, au moins : - un tube (1) fermé par une première extrémité (11) et qui comprend une ouverture (12) sur une deuxième extrémité ; - un piston (2) constitué d'un matériau flexible, sans tige d'actionnement, monté à l'intérieur du tube (1) avec la possibilité de se déplacer dans le sens longitudinal et qui comprend un orifice (21) de charge d'un fluide à séparer et à concentrer, et de décharge des fractions séparées, ledit orifice (21) étant pourvu d'un raccord (22) Luer-Lock femelle à valve ; et un conduit (23) d'évacuation, pourvu d'un filtre auto-obturant (24) pour l'évacuation automatique de l'air/gaz présent dans le tube (1) pendant le remplissage du tube (1) avec le fluide à séparer et concentrer ; et - un bouchon (3) de protection de l'ensemble raccord/piston, pouvant être couplé à l'ouverture du tube.
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16/468,131 US11071690B2 (en) | 2016-12-16 | 2017-11-20 | Sealed sterile device for the aseptic separation and concentration of biological components |
EP17881166.7A EP3556292B1 (fr) | 2016-12-16 | 2017-11-22 | Dispositif fermé et stérile pour la séparation et la concentration aseptiques de composants biologiques |
CA3045894A CA3045894C (fr) | 2016-12-16 | 2017-11-22 | Dispositif sterile scelle pour la separation et la concentration aseptiques d'elements biologiques |
ES17881166T ES2879837T3 (es) | 2016-12-16 | 2017-11-22 | Dispositivo cerrado y estéril para la separación y concentración aséptica de componentes biológicos |
RU2019118386A RU2718314C1 (ru) | 2016-12-16 | 2017-11-22 | Герметично уплотненное устройство для асептического разделения и концентрации биологических компонентов |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ES201631598A ES2675279B2 (es) | 2016-12-16 | 2016-12-16 | Dispositivo cerrado y estéril para la separación y concentración aséptica de componentes biológicos |
ESP201631598 | 2016-12-16 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2018109246A1 true WO2018109246A1 (fr) | 2018-06-21 |
Family
ID=62558091
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/ES2017/070768 WO2018109246A1 (fr) | 2016-12-16 | 2017-11-22 | Dispositif fermé et stérile pour la séparation et la concentration aseptiques de composants biologiques |
Country Status (7)
Country | Link |
---|---|
US (1) | US11071690B2 (fr) |
EP (1) | EP3556292B1 (fr) |
CA (1) | CA3045894C (fr) |
ES (2) | ES2675279B2 (fr) |
PT (1) | PT3556292T (fr) |
RU (1) | RU2718314C1 (fr) |
WO (1) | WO2018109246A1 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114025878A (zh) * | 2019-06-26 | 2022-02-08 | 萨斯特德特股份有限两合公司 | 用于封闭用来容纳液体的试样小管的封闭盖 |
Citations (6)
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US6849052B2 (en) * | 1999-12-13 | 2005-02-01 | Arkray, Inc. | Body fluid measuring apparatus with lancet and lancet holder used for the measuring apparatus |
ES1059764U (es) | 2005-03-07 | 2005-06-01 | M. Dolores Espinos Fabo | Dispositivo para la separacion y recuperacion de fluidos en medicina. |
EP2077115A1 (fr) * | 2006-10-27 | 2009-07-08 | Nipro Corporation | Séparateur de plasma riche en plaquettes et procédé de séparation de plasma riche en plaquettes |
US20110083978A1 (en) * | 2009-10-13 | 2011-04-14 | Cytomedix, Inc. | Kit for separation of biological fluids |
ES2437541B1 (es) | 2012-07-03 | 2014-11-25 | Biotechnology Institute, I Mas D, S.L. | Dispositivo para la extracción, el almacenamiento y/o el procesado de sangre u otras sustancias de origen humano o animal, y para la aplicación de compuestos sanguíneos u otros compuestos biológicos |
US20140358033A1 (en) * | 1998-05-29 | 2014-12-04 | Lawrence A. Lynn | Luer Receiving Air Evacuated Blood Collector |
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US3735900A (en) * | 1971-05-13 | 1973-05-29 | Prod Res & Chem Corp | Dual ingredient storage, intermixing and dispensing storage |
US4644807A (en) * | 1985-02-21 | 1987-02-24 | Dionex Corporation | Fluid sample delivery apparatus |
US4936315A (en) * | 1988-10-20 | 1990-06-26 | Lineback Paul I | Methods and apparatus for obtaining arterial blood samples |
US7179391B2 (en) * | 2002-05-24 | 2007-02-20 | Biomet Manufacturing Corp. | Apparatus and method for separating and concentrating fluids containing multiple components |
US8425239B2 (en) * | 2009-07-09 | 2013-04-23 | Tyco Electronics Corporation | Electrical connector for a solar module assembly |
US9804070B2 (en) * | 2013-03-26 | 2017-10-31 | Alliance Partners, Llc | Biological fluids concentration assembly |
-
2016
- 2016-12-16 ES ES201631598A patent/ES2675279B2/es active Active
-
2017
- 2017-11-20 US US16/468,131 patent/US11071690B2/en active Active
- 2017-11-22 CA CA3045894A patent/CA3045894C/fr active Active
- 2017-11-22 EP EP17881166.7A patent/EP3556292B1/fr active Active
- 2017-11-22 PT PT178811667T patent/PT3556292T/pt unknown
- 2017-11-22 WO PCT/ES2017/070768 patent/WO2018109246A1/fr active Search and Examination
- 2017-11-22 ES ES17881166T patent/ES2879837T3/es active Active
- 2017-11-22 RU RU2019118386A patent/RU2718314C1/ru active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20140358033A1 (en) * | 1998-05-29 | 2014-12-04 | Lawrence A. Lynn | Luer Receiving Air Evacuated Blood Collector |
US6849052B2 (en) * | 1999-12-13 | 2005-02-01 | Arkray, Inc. | Body fluid measuring apparatus with lancet and lancet holder used for the measuring apparatus |
ES1059764U (es) | 2005-03-07 | 2005-06-01 | M. Dolores Espinos Fabo | Dispositivo para la separacion y recuperacion de fluidos en medicina. |
EP2077115A1 (fr) * | 2006-10-27 | 2009-07-08 | Nipro Corporation | Séparateur de plasma riche en plaquettes et procédé de séparation de plasma riche en plaquettes |
US20110083978A1 (en) * | 2009-10-13 | 2011-04-14 | Cytomedix, Inc. | Kit for separation of biological fluids |
ES2437541B1 (es) | 2012-07-03 | 2014-11-25 | Biotechnology Institute, I Mas D, S.L. | Dispositivo para la extracción, el almacenamiento y/o el procesado de sangre u otras sustancias de origen humano o animal, y para la aplicación de compuestos sanguíneos u otros compuestos biológicos |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114025878A (zh) * | 2019-06-26 | 2022-02-08 | 萨斯特德特股份有限两合公司 | 用于封闭用来容纳液体的试样小管的封闭盖 |
CN114025878B (zh) * | 2019-06-26 | 2023-07-04 | 萨斯特德特股份有限两合公司 | 用于封闭用来容纳液体的试样小管的封闭盖 |
Also Published As
Publication number | Publication date |
---|---|
RU2718314C1 (ru) | 2020-04-01 |
ES2879837T3 (es) | 2021-11-23 |
US20200069521A1 (en) | 2020-03-05 |
ES2675279A1 (es) | 2018-07-10 |
ES2675279B2 (es) | 2018-12-21 |
EP3556292A4 (fr) | 2020-05-13 |
EP3556292A1 (fr) | 2019-10-23 |
PT3556292T (pt) | 2021-06-23 |
CA3045894A1 (fr) | 2018-06-21 |
US11071690B2 (en) | 2021-07-27 |
CA3045894C (fr) | 2023-10-31 |
EP3556292B1 (fr) | 2021-04-07 |
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